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Auriga Research Pvt Ltd offer service "Bioequivalence Studies"

Basic Information

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Trade Type

Offer Service

Service Name

Bioequivalence Studies

Service Provider(s)

Specifications

  • Service Scope: Supports pre-approval changes to pioneer NDA products, ANDA submissions, and post-approval changes via bioequivalence studies.
  • Batch Scale: Operates 84 study beds and has completed more than 200 BE studies using over 120 validated methods.
  • Regulatory Certification: Approved by Malaysia's NPRA and India's DCGI (CDSCO-accredited); runs studies under ICH-GCP and FDA-aligned SOPs.

Other Information

Additional Description:

Bioequivalence studies support certain pre-approval changes to pioneer NDA products, ANDA submissions, and post-approval changes. This facility operates 84 study beds, has completed more than 200 BE studies using over 120 validated methods, and is approved by Malaysia's NPRA and India's DCGI (CDSCO-accredited). Its experienced team of doctors, nurses, and pharmacists runs studies in both healthy volunteers (including female-specific studies) and patients under ICH-GCP and FDA-aligned SOPs, backed by an independent quality assurance team conducting online audits; supplied from China, India, North Korea, and Malaysia.
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